BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAUTERINE DEVICE (IUD)

    MDR report key: 15028909 · Received July 14, 2022

    Report

    Report Number
    MW5110900
    Event Type
    Injury
    Date Received
    July 14, 2022
    Date of Event
    July 7, 2022
    Report Date
    July 14, 2022
    Manufacturer
    UNK
    Product Code
    HHF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CALLER STATED THAT SHE HAS BEEN USING INTRAUTERINE DEVICE (IUD) FOR ABOUT THREE MONTHS. LATELY SHE STARTED EXPERIENCING REACTIONS WHICH INCLUDE EXTREME FATIGUE, SEVERE ABDOMINAL CRAMPING, NEW DEPRESSION, ANXIETY AND HIGH BLOOD PRESSURE. SHE STATED SHE NEVER HAD THIS SYMPTOMS BEFORE THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111628 INTRAUTERINE DEVICE (IUD) REMOVER, INTRAUTERINE DEVICE, CONTRACEPTI HHF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Required Intervention